Biosan BioMagPure 12 Plus User manual

Edition v1.6.3

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TABLE OF CONTENTS
1. Introduction....................................................................................................................4
2. Safety information..........................................................................................................5
3. Installation 7
4. Getting started.............................................................................................................12
5. Cleaning and maintainance.........................................................................................16
6. Troubleshooting...........................................................................................................17
7. Specifications ..............................................................................................................19
8. Replacement/Optional Parts........................................................................................19
9. Product Guarantees ....................................................................................................20
10. About services.............................................................................................................20
11. Notes for Transporting/Shipping..................................................................................20
12. Instrument transportation insert before transport.........................................................21

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1. Introduction
Thank you for purchase of the BioMagPure 12 Plus system, which is a fully automated,
standalone robot that can purify nucleic acids within 30-45 minutes. With advanced magnetic bead
separation technology, it enables you to have high quality extraction results. Moreover, the most user-
friendly interface makes users free from troublesome parameter settings and maintenance.
This guide contains important information regarding the safe use of the BioMagPure 12 Plus
system. Please read this manual carefully before you start to run the system at the first time, especially
for Safety Information.
If there is any question about how to install or operate it, please contact our certified distributors
/ agents or email to our technical support centre ( [e-mail] ).
Manufacturer Info:
Biosan SIA
Ratsupites 7, build.2, Riga, LV-1067, Latvia
Phone: [phone] Fax: [phone]
http://www.biosan.lv
BioMagPure Magnetic Bead Purification Process

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2. Safety information
The meanings of safety precaution marks are as follows:
Warning! This indicates a dangerous condition that may lead to death or serious injury. Non-
compliance with instructions or procedures may lead to physical injury or even
death or could cause damage to the instrument.
Warning! Biohazard! This symbol is used to indicate that certain precautions must be taken
when working with potentially infectious material.
Note. Shows the important notes for usage, as well as prohibited actions. It also indicates
the notes, procedures that should be obeyed and supplementary information for
use.
Warning! Hot surface! This symbol is used to label potentially hot instrument surfaces.
IVD This symbol is In vitro diagnostic medical device.
For your safety and that of others, follow the guidelines provided in the following pages con-
cerning the use of the BioMagPure 12 Plus system.
2.1. About Instrument
Warning! Ignoring the following notations may lead to fire or electric shock.
- In countries other than Taiwan, US and Canada, use a power cable that meets your country’s
standard, or contact your local distributor.
- Do not use the BioMagPure 12 Plus system with voltage other than the voltage specified on
the device.
- Do not use the BioMagPure 12 Plus system with a damaged power plug or a loose socket.
- If there is dust on the prongs of the power plug or on the plug socket, remove it with a dry
cloth.
- When you disconnect the plug from the outlet, be sure to hold the power plug itself. Do not
pull the power cable.
- For maintenance, disconnect the power plug from the outlet.
- Do not touch the power plug when you hear the crash of thunder.
- Do not pour any liquid on the BioMagPure 12 Plus system.
- Do not place any objects containing liquid on the BioMagPure 12 Plus system. Doing so may
cause a device failure, fire, or electric shock.
- In the event the device overheats, starts to smoke or smells strange, immediately unplug the
power cable.
- Never attempt to remodel the BioMagPure 12 Plus system without the manufacturer’sper-
mission. Doing so may cause fire or electric shock.
- Do not place or drop objects on the BioMagPure 12 Plus system. Also, refrain from bumping
or knocking it, as doing so may cause a failure or malfunction of the BioMagPure 12 Plus sys-
tem.

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- If any liquid materials are left inside the device, wipe it up a soft paper tissue, etc. Otherwise,
the BioMagPure 12 Plus system may be damaged.
- Repairs to the BioMagPure 12 Plus system should only be performed by such agencies as
are specifically authorized by the ZINEXTS LIFE SCIENCE CORPORATION.
- Only original the ZINEXTS LIFE SCIENCE CORPORATION replacement parts should be
used.
- If the equipment is used in a manner not specified by the manufacturer, the protection pro-
vided by the equipment may be impaired.
2.2. About Reagent Kits
Warning! When handling any of the kits, refer to the respective handbook.
- Reagents in each kit should be handled by observing the safety information and precautions
regarding the kit.
- Extraction should be performed in an appropriate laboratory or workplace.
Note. The kits are not supplied with the BioMagPure 12 Plus system. Select the desired
kit(s) and order it (them) separately.
2.3. About Samples
Warning! Biohazard! Always wear appropriate gloves, a mask, and safety goggles etc. when
handling any infectious samples.
2.4. About Infectious Wastes
- When handling or disposing of infectious materials, follow the laboratory guideline or the law
regarding infectious waste to perform proper incineration, fusion, sterilization, and/or disinfec-
tion.
- When you use a third party to dispose of it, outsource this work an operator licensed to han-
dle medical waste subject to special control, and give them the manifest of the medical waste
at the same time.
2.5. Biosan Service Centre
For technical problem and instrument maintenance, http://tw.dictionary.yahoo.com/diction-
ary?p=maintainceplease contact our service centre on our website www.biosan.lv or by e-mail, ser-
[email protected].

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3. Installation
3.1. Composition of the BioMagPure 12 Plus system. Check that the following are included in
the package. Contact your local representative if you notice any missing part(s).
A B C
D E F
- A. BioMagPure Instrument.............................................................................................1
- B. Power Cable ............................................................................................................1
- C. Sample Tube Rack....................................................................................................2
- D. Barcode Reader ......................................................................................................1
- E. User’s Manual ...........................................................................................................1
- F. M-axis Module...........................................................................................................1
3.2. Please make all the components are free from damages as soon as you get the system. If any
damage found, please contact your local representative for the instant support.
Note. Biosan’s global warranty does not cover the damages from the transportation or
improper operation.

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3.3. Contents of Reagent Kits
Reagent Cartridge(s) Reaction Chamber(s) Tip holder
Piercer Filtered tip Sample tube Elute tube
Note. Reagent kits are separated purchase. Please contact your local agents or repre-
sentatives to get further info. The contents of reagent kits will be various. Refer to
the handbook of kits enclosed in reagent box for details.
3.4. Operating Environment / Condition. Use the BioMagPure 12 Plus system in a location that
meets the following conditions:
The space for the allocation of the BioMagPure 12 Plus system must be remained 5-10 cm
from instrument to sidewalls.
A location where power can be provided.
A location where the temperature is 15 to 40°C and humidity is 30 to 80%RH. (non condensing)
A location that is flat and stable, with no vibration.
A location away from direct sunlight. (Block the sunlight by closing curtains or blinds as neces-
sary)
A location, which is well ventilated and not dusty.
A location where the temperature does not go up and down suddenly. (Warming a cold room
suddenly or moving the BioMagPure 12 Plus system from a room with low temperature to a
warm room may cause condensation inside the device, resulting in abnormal extraction)
A location where the temperature and humidity are kept within the specified range (far from
water taps, water heaters, humidifiers, air-conditioners and heaters)
A location far from objects, which generate strong magnetic fields such as motors, transform-
ers, TV, audio speakers, magnets, etc. Bringing the BioMagPure 12 Plus system close to any
type of magnetic field may cause a malfunction.

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Warning! Do not use the BioMagPure 12 Plus system to a location where it is wet or can be
splashed with water. It may cause a device failure, fire, or electric shock.
When relocating the BioMagPure 12 Plus system, disconnect the plug from the
outlet first. If the power cable is damaged, this may cause a device failure, fire,
injury, or electric shock.
Caution! Do not use the BioMagPure 12 Plus system in an unstable place such as a slanted
surface or a place subject to vibrations. It may cause injury or device failure.
Do not use the BioMagPure 12 Plus system in direct sunlight or close to a heating
device. It may shorten the life of the BioMagPure 12 Plus system, or cause a trou-
ble.
Do not open the maintenance door while performing experiment.
Do not open the drawer while performing experiment.
3.5. Operating Conditions
Items
Conditions
Temperature (°C)
During operation
15 –40
During down time
0 –55
Humidity (RH)
During operation
30 –80
During down time
10 –80
Max. wet bulb temperature (°C)
During operation
29 (non condensing)
During down time
29 (non condensing)
Temperature gradient (°C/hr)
12 or less (non condensing)
Humidity gradient (RH/day)
30 or less (non condensing)
Altitude, operating (m)
1600 or less
3.6. Unpacking of the BioMagPure 12 Plus system
3.6.1. Open the packing box and take out the instrument and related accessories.
Note. The BioMagPure 12 Plus system has a weight of more than 60 kg. It should be lift
and moved by two persons. Hold the moving handler of the instrument from two
sides to move it out from the box. Do not lift by the outer covering, front panel or
the door.
Caution! Improper handling of the movement of the BioMagPure 12 Plus system will lead to
instrument damages.
3.6.2. For correct and safe use of the BioMagPure 12 Plus, install it in a location that is close to
electrical outlet and has enough space for installation and operation of the mains switch.
Note. Keep the shipping box and stuffing materials. They will be needed again when
transporting the BioMagPure 12 Plus system.
3.6.3. Connect Barcode Reader with the Instrument, see 3.7.

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3.6.4. Before turn on the power please make sure screw-out the screw which uses to lock the X-axis
in the RIGHT inside of bar.
- Tool:(4MM hex tool)
- Direction: Counter clockwise at least 3 turns
3.6.5. How to remove the transportation insert inside the instrument following the steps below,
3.6.5.1 Plug in the power cable to the instrument and connect to electric outlet
3.6.5.2 Turn the power switch on.
3.6.5.3 Press “START”button. The piston module will going up, and you can release the transportation
insert.
3.7. Overall View
Front view with Door closed Front view with Door opened

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LCM Panel and Control Pad Control pad, close view
- LCM displays information of operation instruction guide and program process status.
- Control pad is used for selection of functions and input of program and test codes.
Rear panel

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4. Getting started
Caution! Biohazard!Always wear appropriate gloves, a mask, and safety goggles during any
biohazardous operations in extraction process. Even when touching the device af-
ter any operation with a biohazard risk, wear appropriate gloves and a mask since
the device may be contaminated.
Note. Before starting extraction, put on appropriate gloves, a mask, and safety goggles
if required by the operation. In the operation from preparing samples to extraction
completion, be careful not to contaminate the samples with sweat, saliva, etc.
4.1. Turning on the power. Make sure that the power cable are connected securely to the BioMag-
Pure 12 Plus system. Connect the plug of the power cable to the outlet.
4.2. Preparation. User must prepare individual protection, such as gloves, masks and safety gog-
gles. For the preparation of samples, refer to the handbook of each kit. Following items are
provided with reagent kits: reagent cartridge, reaction chamber, tip holder, small tip (optional),
filtered tip, sample tube, elute tube, piercing pin.
4.3. Extraction.
4.3.1. Turn the power switch on and waiting for the LCM screen turn on and shows “BioMagPure 12
Plus System Stand-By”.
4.3.2. Press the “Start”button. The system will process self-testing, and then go to steady mode.
Note. The system will block main functions before the completion of self-testing process.
4.3.3. Open the drawer and remove the sample rack from the instrument.
4.3.4. Load Reagent Cartridges, and all plastics disposables (Reaction Chamber, Tip Holder, Pierc-
ing Pin, Filtered Tip and Sample Tube and Elute Tube. (Optionally supplied with some kit
types). To pull apart reagent cartridges, slash open the dotted line with cutter.
Divide the cartridges Insert the cartridges

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Insert Reaction Chambers Insert Tip Holder
Insert Piercing Pins Insert Filtered Tips
Note. The positions of piercing pin and filtered tip are displayed below, leave middle row
empty!
4.3.5. Load one Reagent Cartridge and one set of plastic disposable per sample. Set Cartridges in
the order of the number from left to right. Make sure that Cartridges are inserted in to the
Cartridge Tray tightly. You can load 1-12 cartridges on the tray depending on the number of
samples that you wish to process.

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4.3.6. Load Sample Tube and Elute Tube to Sample Rack on the bench
Sample tube Elute tube
4.3.7. Load the sample(s) to Sample Tube. Place Sample Rack on the instrument platform.
Distribute samples Place sample and elute rack
Note. Pre-treatments are essential for some sample types before loading to Sample
Tube. Please refer to the handbook of reagent kits for details.
Make sure the caps of Elute Tube are open as the figure shown above.
Use two hands to handle the Sample Tray.
Make sure the Sample Tray be placed correctly in the instrument
4.3.8. Close the Drawer.
4.3.9. Scan the protocol barcodes to select purification protocol, sample volume and elute volume
Note. There is one protocol barcode paper enclosed in the reagent kit box. Protocol’s
name, sample volume and elution volume will be shown on LCM screen after pro-
tocol barcode is scanned.
4.3.10. Follow the instructions displayed on LCM screen to double check the operating steps being
completed before program running.

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4.3.11. Push “Enter” to confirm. Instrument will start to run the protocol program automatically until
whole processes are completed.
Note. It will take times to complete the extraction according to reagent types.
4.3.12. At the end of the run, the instrument beeps briefly and the LCM shows “Protocol Completed”.
4.3.13. Open the drawer.
4.3.14. Remove the elute tubes containing the purified nucleic acid.
Note. Store the purified nucleic acids at 4℃for short-term storage or store at -70℃for
long-term storage.
4.3.15. Discard the used cartridges, all plastic consumables into biohazard waste. Do not reuse the
cartridges.
4.3.16. If you are not using the instrument, place the Sample Rack back to workplace, close the instru-
ment door and push “Start”button for 2 seconds to get into “sleeping mode”. In addition, for
longer time not using the instrument turn the power switch off.
4.4. After Extraction Operation
4.4.1. Take out the Elute Tubes (The extraction yields in them).
Note. You can apply quality checking or do downstream study or storage them as what
you expect.
4.4.2. Remove the Cartridges and plastic disposables from the instrument and then dispose of them.

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5. Cleaning and maintainance
5.1. Two types of maintenance are performed on the BioMagPure 12 Plus system Instrument as
listed in the table. For details on each type of maintenance, see below:
Maintenance Type
Performed by
Schedule
Cleaning of Sample Tray
User
After each use
Cleaning of instrument body (outside)
Bi-weekly
Cleaning of instrument body (inside)
Preventive
Service Engineer
Annually
5.2. Clean the Sample Tray with mild detergent and rinse with deionized water. Allow the parts to
dry before use. Clean and disinfect the platform surface by wiping with deionized water followed
by 75% ethanol.
5.3. Clean the instrument body by removing dust gently with a dry, soft cloth. If the outside of the
BioMagPure 12 Plus system is heavily soiled, or if any samples that may cause infection are
adhered to the outside of the BioMagPure 12 Plus system, wipe with a soft paper tissue,
soaked with 0.5% sodium hypochlorite solution or ethanol.

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6. Troubleshooting
Problem
Cause
Solution
Instrument Problems
No power (the LCM
Screen remains blank
when the power is
turned on)
AC power cable is not connected
Check AC power cable connections at both ends. Alter-
natively, Use the correct cables.
LCM Screen turns on
when the power is on
but the self-testing pro-
gram does not run
Forget to remove the packing stuff
from instrument
Turn off the instrument and remove the packing stuff.
Technical problem
Contact your local representative or agent
Protocol stops after an
initial start
Cartridge(s), Plastic wares (Reaction
Chamber, Tip Holder, Filtered Tip,
Sample Tube, Elute Tube) incorrectly
loaded on the BioMagPure 12 Plus
system
Turn off the power and then turn it on again to stop the
program. The system will move back to initial state. Re-
load them according to the instructions shown in this
manual.
Note. You could not resume the protocol after stop and
you may lose your samples.
Problem with motion sensors
Turn off the power and remove all samples and plastic
wares. Contact your local representatives
Bubbles formed during
extraction
Missed adding sample or sample vol-
ume is lower than the recommended
volume
Be sure to add the sample to tubes prior to starting the
protocol. To ensure proper mixing of reagents in the tip
and prevent bubble formation during mixing, make sure
the sample volume is at least the recommended volume
listed in the handbook supplied with the BioMagPure Re-
agent Kits.
Presence of buffer in the
Cartridge Tray
Motor movements may not be
smooth, incorrect placement of plas-
tic ware, or leakage from tips
Perform preventive maintenance annually to ensure
proper motor movements.
Leakage from Filtered
Tips or uneven liquid
handling between Fil-
tered Tips
Air leakage on the Filtered Tip
Swap the air-leaked Tip with new one
Blockage of tips and pi-
petting failure
Too much starting material or excess
DNA in sample causing clumps or ag-
gregates
Decrease the amount of starting material. Use the rec-
ommended amount of starting material as listed in the
Reagent Kit manual (Handbook).
Suggest using blood kit 1200 instead of blood kit 200 (if
testing sample is blood)

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DNA Quality Problems
Problem
Cause
Solution
Low DNA yield
Incomplete lysis
Decrease the amount of starting material used.
Be sure to add Proteinase K during lysis, if included in
the protocol.
Make sure that the sample is completely immersed in
the Lysis Buffer.
Poor quality of starting material
Be sure to process sample immediately after collection
or store the sample at appropriate temperature. The
yield and the quality of DNA isolated depend on the
starting material.
Insufficient amount of magnetic
beads added
During shipping, some magnetic bead solution may ad-
here to the sealing foil of the cartridge. To collect any
bead solution from the foil, tap the cartridge to deposit
the bead solution at the bottom of the well.
Clogged Tips resulting in DNA loss
Ensure that the lysate does not contain any particulate
material that can clog the tip sprout. If needed, centri-
fuge the sample prior to the BioMagPure purification.
No DNA recovered
Magnetic beads stored or handled
improperly
Store cartridge containing the beads at room tempera-
ture.
Do not freeze the cartridge as the beads may be irrepa-
rably damaged.
Make sure that the beads are in solution at all times and
do not dry. Dried beads are non-functional.
Elute containing DNA
is discoloured
Magnetic beads present in the elute
Remove any magnetic beads using a magnetic separa-
tor or centrifuge the sample in a micro centrifuge for 1
minute at maximum speed.
DNA contaminated with heme
Minimize the amount of blood or bloodstained sample
used (≤ 20μl blood spot for forensics sample).
DNA is sheared or de-
graded
Bubbles formed during mixing steps
To prevent bubble formation during mixing, make sure
the sample volume is at least the recommended volume
listed in the manual supplied with Reagent Kits.
Purified DNA repeatedly frozen and
thawed
Aliquot purified DNA and store at 4°C (short-term) or -
20°C (long-term). Avoid repeated freezing and thawing.
DNA contaminated with DNases
Maintain a sterile environment while working (i.e. wear
gloves and use Dnase-free reagents).

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7. Specifications
The unit is designed for operation in cold rooms and closed laboratory rooms at ambient tem-
perature from +15°C to +40°C in a non-condensing atmosphere and maximum relative humidity 80%
for temperatures up to 31°C decreasing linearly to 50% relative humidity at 40°C.
Biosan is committed to a continuous programme of improvement and reserves the right to alter
design and specifications of the equipment without additional notice.
Sample processing
1 to 12 samples per batch
Sample volume handling
100 –1200μL
Processing time
See purification kit manual for details
Heat block temperature
60°C to 70°C (assuming the room temperature of ~25°C)
Protocol input
Barcode Reader
UV light
30 minutes @ 250 nm
Display
LCD Screen
Instrument dimensions
56 cm W x 51 cm D x 59 cm H
Weight
60 kg
Input power
AC 100-240 V, 240 VA, 50/60 Hz
Fuse
F3.15A 250V
7.1. Applicable standards:
LV directive (73/23/EEC)
EMC directive (89/336/EEC) EN61326-1
Safety EN61010-1, EN61010-2-101
8. Replacement/Optional Parts
Item
Q’ty
Parts No.
Barcode Reader
1
A01001
Power Cable
1
A01002
Sample Rack
1
A01003
Filtered Tip
50
A02001
Piercing Pin
50
A02004
Sample Tube
50
A02002
Elute Tube
50
A02003

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9. Product Guarantees
9.1. The warranty period shall be one year from the delivery of the product.
9.2. Any part, which fails to function properly under normal use, if all warnings and cautions in this
manual are observed, during the warranty period will be repaired by the Manufacturer.
9.3. If the problem is due to the causes listed below, some charge may be applied for the repair
even within the warranty period.
9.3.1. Any failures due to improper use or that are affected by other devices except for those ap-
proved by the Manufacturer.
9.3.2. Any malfunctions or damages during transportation or due to dropping of the product by a user.
10. About services
10.1. Before you ask for device repairs, refer to “4 Troubleshooting” to check the problems. If the
problems cannot be solved, contact your local representative, or the relative customer support.
11. Notes for Transporting/Shipping
11.1. Before carrying the BioMagPure 12 Plus system, disconnect the plug from the outlet. If the
power cable is damaged, this may cause a device failure, fire, injury, or electric shock.
11.2. Remove all attached parts (Sample Rack, Barcode Reader) from the BioMagPure 12 Plus sys-
tem.
11.3. After completing the above tasks, pack the BioMagPure 12 Plus system in its original shipping
box or some other equivalent box.